Issued by the Food and Drug Administration
(FDA) in 1997, 21 CFR Part 11 reinforces FDA regulations on electronic
record keeping and the use of electronic signatures. The rule was created
in reaction to the trend among pharmaceutical companies and medical
device manufacturers to use the Internet to speed up communications
and share data such as trial results.
Contact Us
Select any of the services below for more information.
To design a more comprehensive compliance solution for your business,
contact VeriSign at 650-426-5310 or enterprise_security@verisign.com.
Requirements
These VeriSign products and services can help
address FDA 21 CFR Part 11:
Key Controls |
Applies To |
How VeriSign Helps |
Requires regular risk
assessment and mitigation |
All systems storing, transmitting and processing
protected data (electronic medical and pharmaceutical records) |
Enterprise
Consulting Assessments |
Requires access control
and authentication |
All systems storing protected data
|
Unified
Authentication |
Requires encryption and
digital signatures |
All systems transmitting or storing protected
data |
|
Requires 24/7 management
of network security infrastructure |
Applications, servers, databases, and network
devices with protected data |
|
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